An Expedited Regulatory Strategy For Expanding Access To Methadone Treatment For Opioid Use Disorder

There were more than 107,000 overdose deaths in the United States in 2021, of which approximately 80,000 involved opioids. There are effective, evidence-based treatments for opioid use disorder (OUD) that could have averted tens of thousands of these deaths, but they are inaccessible to many people. Perhaps nowhere is this truer than in the case of methadone. Although this medication is an effective treatment for OUD that dramatically reduces overdose deaths and other opioid-related harms, significant and inequitable barriers currently impede access to it.

Chief among these barriers is long-entrenched legal requirements that limit methadone treatment to federally authorized opioid treatment programs, which are subject to tight regulatory requirements. This restrictive legal regime prevents most medical providers and pharmacies from prescribing or dispensing methadone for OUD treatment and contributes to the stigma associated with the medication. Among other impediments, existing requirements force many patients to travel to an opioid treatment program daily to receive their medicine. This is often impossible, especially in rural areas, effectively precluding access to treatment. Additional restrictions impede the ability of physicians to tailor treatment to individual patient needs and to comply with evidence-based best practices.

President Biden has recognized the importance of acting now to address barriers to methadone treatment access. His 2022 State of the Union Address made “beat[ing] the opioid epidemic” a key priority, and he has called for “universal access” to medications for opioid use disorder (MOUD) by 2025, in part by “eliminating outdated rules that place unnecessary administrative burdens on providers.” We agree with the President that eliminating such rules is an important and necessary step in addressing the crisis. However, this is easier said than done. It requires identification of the specific requirements that warrant change, determination of who has authority to change them, development of measures that may be necessary to avoid unanticipated or undesirable consequences of reform, and, of course, execution through administrative or legislative pathways.

The Biden Administration has demonstrated an awareness of the hard work entailed in removing barriers to methadone treatment. Among other efforts, the Office of National Drug Control Policy—a coordinating agency within the Executive Office of the President—asked the National Academies of Science, Engineering, and Medicine to convene a two-day workshop titled Methadone Treatment for Opioid Use Disorder: Examining Federal Regulations and Laws. The workshop, held in March 2022, brought together patients, providers, attorneys, policymakers and researchers to examine OUD-related issues in depth, identify urgent problems, and propose realistic solutions.

As attorneys who participated in the National Academies’ workshop, we have identified specific next steps that federal agencies have the authority to implement without additional legislation. The actions summarized below collectively represent an immediate, attainable action plan for promotion increased and equitable access to methadone treatment for OUD. If President Biden’s goal of “universal access to MOUD by 2025” is to become reality, agencies must take these steps as soon as possible.

Extend “Take Home” Flexibilities For Methadone

Legal restrictions on patients’ ability to take their methadone doses home with them have been a longstanding barrier to treatment access, often requiring daily clinic visits that are costly, inconvenient, and impossible for some patients. In response to the COVID-19 public health emergency, the Substance Abuse and Mental Health Services Administration (SAMHSA) wisely empowered states and clinics to allow patients to take home up to a 28 day supply of methadone. Initial evidence suggests that this change was associated with an increase in patients receiving take-home doses, with no increase in negative treatment outcomes.

SAMHSA has recently agreed to extend these take-home flexibilities for one year after the COVID-19 public health emergency expires while working on a permanent regulatory solution. However, this extension adds additional restrictions, such as requiring a patient to have negative toxicology tests for 60 days and “demonstrate total adherence” to the OTP’s treatment plan to be deemed “stable” enough to take methadone home for the 28 days permitted under the current guidance. SAMHSA should remove these restrictions while working expeditiously to design and implement new regulations that prioritize the health and well-being of methadone patients by making take-home doses the default, not the exception. If necessary, SAMHSA can and should extend the existing take-home flexibilities under the ongoing “opioid crisis” public health emergency.

Modify Current Regulations Governing Prescribing, Dispensing And Treatment With Methadone

Restrictions on take-home methadone are emblematic of a wide array of legal restrictions that depart from informed clinical judgment and respect for the patient-clinician relationship with regard to addiction treatment. These restrictions impose limits on access to methadone regardless of a patient’s needs and desires or the provider’s clinical judgment and, in some cases, expose patients to unnecessary risks of harm.

As noted above, the most limiting of current requirements for bids most physicians from prescribing methadone for the treatment of OUD, and pharmacies from dispensing it. Even when patients can access an opioid treatment program, they are faced with additional limitations. Restrictions include limits on who can access methadone treatment, mandatory toxicology screens for patients receiving treatment, non-evidence-based criteria for take-home doses, and arbitrary dosing schedules set in federal law that cannot be overruled by the treating physician regardless of the patient’s needs. Together, these restrictions make it more difficult for patients to access methadone than nearly any other medication.

In almost every case, these restrictions can be altered or waived through regulatory authority. SAMHSA and, where necessary, other responsible agencies, should begin public consideration of such changes immediately, and remove those that are not supported by the evidence.

Use Authority Over Public Programs To Monitor And Check Coverage Barriers Imposed By Insurers

Insurance coverage requirements are another source of interference with patient and provider judgments about methadone. Prior authorization, utilization review, and narrow or incomplete networks can prevent access to methadone in employer-sponsored insurance, Medicaid managed care, and Medicare Advantage. Indeed, the Department of Labor’s 2022 parity report to Congress highlighted some of these as significant examples of inappropriate barriers to MOUD treatment, as well as the need for greater investigative and enforcement tools to identify and correct such barriers.

While federal legislation is likely needed to expand the capability of federal and state agencies to address some barriers to methadone treatment imposed by insurance providers, federal agencies could take important steps on their own under existing authority. Specifically, the Centers for Medicare and Medicaid Services (CMS) should consider opioid treatment program coverage in assessing Medicare Advantage network adequacy, re-evaluate and strengthen its risk adjustment model’s application to substance use disorders, and collect and analyze data on barriers in Medicaid managed care. CMS has the authority to do all of these things under existing legislation.

Use Existing Federal Authorities To Incentivize States To Expand Access To Methadone

State policies regulating access to methadone are often more restrictive than federal requirements. Similarly, local legal barriers, such as zoning restrictions, may inhibit their therapeutic effectiveness. Although states are generally permitted to adopt more restrictive policies than federal law requires, federal agencies also have ample authority to incentivize state action through grant administration and policy. For example, the Bureau of Justice Assistance and other agencies can work with state and local correctional institutions to provide support to ensure that methadone is available in correctional settings. CMS could offer states a specific Medicaid demonstration opportunity to encourage them to expand meaningful access to methadone under its Section 1115 waiver authority, including the possibility of enhanced funding associated with such a demonstration through the agency’s fiscal waiver authorities.

CMS’ authority could also be used to incentivize states to implement new models designed to expand methadone access to currently underserved individuals such as those who are pregnant or parenting and in settings such as prisons, jails, long-term care facilities, and inpatient substance use disorder treatment facilities. Moreover, the agency could consider tethering incentives to block grants and other grant programs to ensure states comply with the requirement in Section 1006 of the SUPPORT Act that methadone treatment be available through state Medicaid programs. Finally, federal agencies can offer targeted technical assistance to states and providers to operationalize changes in the federal methadone regulatory framework, implement federal parity rules, adjust Medicaid reimbursement structures to align with best practices for care, and rapidly translate new research into policy and practice.

Increase Enforcement Of The Americans With Disabilities Act

Finally, the federal government can and should do much more to protect the rights of individuals who are receiving methadone. Drug courts, nursing homes, correctional facilities and other agencies and organizations often forbid the use of methadone treatment or refuse to provide access to it, despite the well-documented benefits. Such policies are in direct conflict with best evidence, and likely contribute to the fact that individuals released from carceral settings have extremely high rates of overdose death. Indeed, providing MOUD in correctional settings reduces overdose deaths.

In April 2022 the Civil Rights Division of the Department of Justice issued an enforcement guidance that describes how the Americans with Disabilities Act (ADA) protects people with OUD who are in treatment or recovery, including those who take MOUD. For the first time, this guidance makes clear that a jail that does not allow individuals entering incarceration to continue taking prescribed MOUD, a skilled nursing facility that refuses to admit a patient with OUD because the patient takes MOUD, and a doctor’s office that refuses to treat patients receiving treatment with OUD are all violating the ADA. This is a major step forward. All federal civil rights enforcement agencies, including US Attorneys’ Offices and HHS’s Office of Civil Rights, should treat protection of methadone patients’ civil rights as a top enforcement priority. They should vigorously investigate and pursue violations by jails, providers, or other entities.

Conclusion

Treatment with methadone dramatically improves the lives of people with OUD and should be universally available to those who wish to access it. However, law and policy continue to create barriers to this life-saving treatment – ​​barriers that fall disproportionately on already disadvantaged individuals. Many of these barriers can be removed by federal agencies without additional Congressional action. We have identified multiple specific actions that the Biden Administration can immediately take to follow through on the President’s commitment to curbing overdose deaths and related harm. It is imperative that these changes be incorporated into the National Drug Control Strategy and that federal agencies immediately take steps to adopt them.

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